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Registry on the Use of HaemoCER-Plus in the Treatment and Prevention of Post-resectional Bleeding

Prospective Multicenter Registry on the Use of HaemoCer-PLUSPlus in the Treatment and Prevention of Post-resectional Bleeding

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05443815
Acronym
HemoCER
Enrollment
50
Registered
2022-07-05
Start date
2022-07-01
Completion date
2023-07-30
Last updated
2022-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-resectional Bleeding

Brief summary

Gastrointestinal bleeding is defined as clinical evidence of bleeding manifested by melena, hematochezia that required endoscopic hemostasis. GI bleeding associated to endoscopic procedure is defined as clinical evidence of bleeding and a drop in hemoglobin of ≥ 2g/dL on the day of the procedure (early bleeding) or up to 14 days after the procedure (delayed bleeding).GI bleeding is, nevertheless, a common complication of endoscopic procedures, such as endoscopic mucosal resection (EMR) and endoscopic sub mucosal dissection (ESD). For example, colorectal ESD, which is technically more difficult than gastric or esophageal ESD because of the anatomical features of the colon, present an increased risk of delayed bleeding. According to literature, early bleeding occurs on average in 5,3% of endoscopic resections of the whole digestive tract, with bleeding rates per location as follows: esophagus 9.4%, stomach 9.1%, duodenum 3.6%, colon 3.4%. Concerning delayed bleeding, it is assessed to complicate 3.1% of endoscopic resection procedures. The bleeding rate in the duodenum is usually the highest (6.3%), followed by colon at (3.6%), stomach (1.5%) and esophagus (0.9%). Age, lesion size and piecemeal resection are associated with an increased risk of bleeding. Usage of aspirin or NSAIDs seems to not increase risk of post-polypectomy bleeding, while clopidogrel and warfarin do and should be discontinued in the periprocedural period to prevent the occurrence of post-polypectomy bleeding. Direct oral anticoagulants (DOAC) administration shows similar post-procedural gastrointestinal bleeding risk to anti-vitamin K antagonists (VKA) administration in patients undergoing endoscopic procedures.

Interventions

DEVICEHaemoCer-PLUS

HaemoCer-PLUS

Sponsors

Istituto Clinico Humanitas Mater Domini
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* patients who had authorized to use and process their personal details for the purpose of research; * patients able to express their consent; * age \>18 years; * endoscopic procedures where HaemoCer-PLUS has been used for hemostasis or prevention of bleeding

Exclusion criteria

* hemostatic therapies other than HaemoCer-PLUS * Known coagulopathy likely to affect risk of bleeding.

Design outcomes

Primary

MeasureTime frameDescription
Number and proportion of bleeding events in patients receiving HaemoCer-PLUS6 monthsNumber and proportion of bleeding events controlled by application of HaemoCer

Countries

Italy

Contacts

Primary ContactBenedetto Mangiavillano, MD
benedetto.mangiavillano@materdomini.it00390331476381

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026